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Interest is growing in a standard European treatment for bacterial vaginosis (BV).
In a commentary published in JAMA Network Open, researchers and doctors from the Johns Hopkins University School of Medicine in Baltimore and the University of Maryland, Baltimore, urged clinical trials in the United States to determine if dequalinium chloride — an antiseptic that inhibits the growth of bacteria and fungi — is on par with or better than treatments currently available.
Dequalinium has been used throughout Europe for decades and is recommended as an alternative or second-line BV treatment by the World Health Organization; the International Society for the Study of Vulvovaginal Disease; and the Austrian, German, Portuguese, Spanish, and Swiss Societies of Gynecology and Obstetrics. However, the product has not been approved for clinical use in the United States, no trials studying the drug have been registered on ClinicalTrials.gov, and the US Food and Drug Administration has not received an application for approval, according to agency records.
Treatments in the United States for BV include metronidazole and clindamycin that, while effective, have a recurrence rate of up to 60%.
“Current treatments for bacterial vaginosis often fall short, primarily due to frequent recurrences after treatment,” said Rebecca M. Brotman, PhD, MPH, a professor in the Department of Epidemiology and Public Health at the Institute for Genome Sciences at the University of Maryland School of Medicine, and the corresponding author of the commentary.
More than 40% of people with recurrent BV do not receive adequate treatment, according to Caroline M. Mitchell, MD, MPH, director of the Vulvovaginal Disorders Program at Massachusetts General Hospital Vincent Center for Reproductive Biology, Boston, Massachusetts.
“BV is very disruptive to people’s daily lives and causes significant distress,” said Dr. Mitchell, who was not a coauthor of the new article. “Additionally, BV is associated with higher risk for HPV [human papillomavirus] infection, progression of HPV to cervical dysplasia, as well as risk for acquisition of other sexually transmitted infections.”
Dr. Mitchell said she hopes a recent trial from Europe comparing dequalinium chloride to metronidazole spurs researchers to study its efficacy and safety among women in the United States.
“Dequalinium has some antifungal activity, so it might offer a lower chance of yeast infection after treatment, which is important because posttreatment vulvovaginal candidiasis is one of the downsides to conventional antibiotic treatments,” Dr. Mitchell said.
The recent clinical trial included 147 premenopausal women with BV who received 10 mg of dequalinium per day for 6 days or oral metronidazole (500 mg twice daily for 7 days).
Dr. Brotman said any studies in the United States would need to examine long-term recurrence of vaginosis after treatment with dequalinium chloride and its use during pregnancy.
The study was funded by various grants from the National Institutes of Health and the Gates Foundation. Various authors reported receiving royalties from UpToDate outside the submitted work or receiving a donation of sexually transmitted infection testing kits from Hologic for a study outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
Interest is growing in a standard European treatment for bacterial vaginosis (BV).
In a commentary published in JAMA Network Open, researchers and doctors from the Johns Hopkins University School of Medicine in Baltimore and the University of Maryland, Baltimore, urged clinical trials in the United States to determine if dequalinium chloride — an antiseptic that inhibits the growth of bacteria and fungi — is on par with or better than treatments currently available.
Dequalinium has been used throughout Europe for decades and is recommended as an alternative or second-line BV treatment by the World Health Organization; the International Society for the Study of Vulvovaginal Disease; and the Austrian, German, Portuguese, Spanish, and Swiss Societies of Gynecology and Obstetrics. However, the product has not been approved for clinical use in the United States, no trials studying the drug have been registered on ClinicalTrials.gov, and the US Food and Drug Administration has not received an application for approval, according to agency records.
Treatments in the United States for BV include metronidazole and clindamycin that, while effective, have a recurrence rate of up to 60%.
“Current treatments for bacterial vaginosis often fall short, primarily due to frequent recurrences after treatment,” said Rebecca M. Brotman, PhD, MPH, a professor in the Department of Epidemiology and Public Health at the Institute for Genome Sciences at the University of Maryland School of Medicine, and the corresponding author of the commentary.
More than 40% of people with recurrent BV do not receive adequate treatment, according to Caroline M. Mitchell, MD, MPH, director of the Vulvovaginal Disorders Program at Massachusetts General Hospital Vincent Center for Reproductive Biology, Boston, Massachusetts.
“BV is very disruptive to people’s daily lives and causes significant distress,” said Dr. Mitchell, who was not a coauthor of the new article. “Additionally, BV is associated with higher risk for HPV [human papillomavirus] infection, progression of HPV to cervical dysplasia, as well as risk for acquisition of other sexually transmitted infections.”
Dr. Mitchell said she hopes a recent trial from Europe comparing dequalinium chloride to metronidazole spurs researchers to study its efficacy and safety among women in the United States.
“Dequalinium has some antifungal activity, so it might offer a lower chance of yeast infection after treatment, which is important because posttreatment vulvovaginal candidiasis is one of the downsides to conventional antibiotic treatments,” Dr. Mitchell said.
The recent clinical trial included 147 premenopausal women with BV who received 10 mg of dequalinium per day for 6 days or oral metronidazole (500 mg twice daily for 7 days).
Dr. Brotman said any studies in the United States would need to examine long-term recurrence of vaginosis after treatment with dequalinium chloride and its use during pregnancy.
The study was funded by various grants from the National Institutes of Health and the Gates Foundation. Various authors reported receiving royalties from UpToDate outside the submitted work or receiving a donation of sexually transmitted infection testing kits from Hologic for a study outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
Interest is growing in a standard European treatment for bacterial vaginosis (BV).
In a commentary published in JAMA Network Open, researchers and doctors from the Johns Hopkins University School of Medicine in Baltimore and the University of Maryland, Baltimore, urged clinical trials in the United States to determine if dequalinium chloride — an antiseptic that inhibits the growth of bacteria and fungi — is on par with or better than treatments currently available.
Dequalinium has been used throughout Europe for decades and is recommended as an alternative or second-line BV treatment by the World Health Organization; the International Society for the Study of Vulvovaginal Disease; and the Austrian, German, Portuguese, Spanish, and Swiss Societies of Gynecology and Obstetrics. However, the product has not been approved for clinical use in the United States, no trials studying the drug have been registered on ClinicalTrials.gov, and the US Food and Drug Administration has not received an application for approval, according to agency records.
Treatments in the United States for BV include metronidazole and clindamycin that, while effective, have a recurrence rate of up to 60%.
“Current treatments for bacterial vaginosis often fall short, primarily due to frequent recurrences after treatment,” said Rebecca M. Brotman, PhD, MPH, a professor in the Department of Epidemiology and Public Health at the Institute for Genome Sciences at the University of Maryland School of Medicine, and the corresponding author of the commentary.
More than 40% of people with recurrent BV do not receive adequate treatment, according to Caroline M. Mitchell, MD, MPH, director of the Vulvovaginal Disorders Program at Massachusetts General Hospital Vincent Center for Reproductive Biology, Boston, Massachusetts.
“BV is very disruptive to people’s daily lives and causes significant distress,” said Dr. Mitchell, who was not a coauthor of the new article. “Additionally, BV is associated with higher risk for HPV [human papillomavirus] infection, progression of HPV to cervical dysplasia, as well as risk for acquisition of other sexually transmitted infections.”
Dr. Mitchell said she hopes a recent trial from Europe comparing dequalinium chloride to metronidazole spurs researchers to study its efficacy and safety among women in the United States.
“Dequalinium has some antifungal activity, so it might offer a lower chance of yeast infection after treatment, which is important because posttreatment vulvovaginal candidiasis is one of the downsides to conventional antibiotic treatments,” Dr. Mitchell said.
The recent clinical trial included 147 premenopausal women with BV who received 10 mg of dequalinium per day for 6 days or oral metronidazole (500 mg twice daily for 7 days).
Dr. Brotman said any studies in the United States would need to examine long-term recurrence of vaginosis after treatment with dequalinium chloride and its use during pregnancy.
The study was funded by various grants from the National Institutes of Health and the Gates Foundation. Various authors reported receiving royalties from UpToDate outside the submitted work or receiving a donation of sexually transmitted infection testing kits from Hologic for a study outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN